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Regulatory Affairs Manager

Taipei City Permanent Work from Home or Hybrid View Job Description
This role is responsible for regulatory submissions, lifecycle management, and regulatory strategy development for pharmaceutical products in Taiwan. The successful candidate will lead cross-functional initiatives, engage with health authorities, and drive regulatory excellence while managing a regulatory affairs team.
  • Lead regulatory strategy for innovative pharmaceutical products.
  • Manage a regulatory team and drive key product approval projects.

About Our Client

Our client is a leading global pharmaceutical company dedicated to developing and commercialising innovative medicines that address significant unmet medical needs. With a strong global presence and diverse pipeline, the organisation continues to deliver impactful healthcare solutions worldwide.

Job Description

  • Lead regulatory submissions for new products and post-approval variations in Taiwan
  • Ensure timely approval and maintenance of product registrations in line with business objectives
  • Develop and execute regulatory strategies to support product launches and lifecycle management
  • Manage interactions with health authorities and facilitate review and approval processes
  • Coordinate and oversee responses to regulatory inquiries and deficiency letters
  • Review product labelling, prescribing information, and related documents to ensure regulatory compliance
  • Lead cross-functional discussions and provide regulatory guidance to business stakeholders
  • Support regulatory planning for new product introductions and pipeline development projects
  • Monitor regulatory developments and assess potential business impact
  • Maintain and improve regulatory procedures, policies, and SOPs
  • Lead regulatory projects and provide progress updates to local and global stakeholders
  • Manage team performance and support capability development within the Regulatory Affairs function

The Successful Applicant

Required Qualifications

  • Bachelor's degree or above in Pharmacy, Pharmacology, Biology, or a related discipline
  • Approximately 8 years or more of Regulatory Affairs experience within the pharmaceutical industry in Taiwan
  • Strong knowledge of Taiwan pharmaceutical regulations and registration requirements
  • Proven experience managing regulatory submissions and product lifecycle activities
  • Strong communication, stakeholder management, and project coordination skills
  • Ability to communicate strategic and operational issues effectively to senior management
  • Fluent English communication skills, both written and spoken



Preferred Qualifications

  • Experience with New Chemical Entity (NCE) submissions
  • Knowledge of clinical development and regulatory requirements
  • Experience within a multinational pharmaceutical environment
  • Demonstrated experience in regulatory strategy development and product launches

What's on Offer

  • Opportunity to lead regulatory strategy for a diverse pharmaceutical portfolio
  • Exposure to product launches and pipeline development projects
  • Close collaboration with regional and global stakeholders
  • Leadership responsibility within a multinational pharmaceutical organisation
  • Additional compensation and benefits details: To be confirmed
Contact
Benson Huang
Quote job ref
JN-102026-7125643
Phone number
+88 6287298210

Job summary

Job function
Life Sciences
Specialisation
Regulatory Affairs
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Taipei City
Contract Type
Permanent
Consultant name
Benson Huang
Consultant phone
+88 6287298210
Job Reference
JN-102026-7125643
Work from Home
Work from Home or Hybrid

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.